Glossary

On this page you will find a description of words that you might hear doctors and nurses say or read on forms whilst taking part in research at the facility.

Clinical trial: A research study to answer specific questions about vaccines, new therapies and new ways of using known treatments. Clinical trials are used to determine whether new drugs and treatments are both safe and effective. Trials are in four phases.

• Phase I tests a new drug or treatment in a small group, where the investigator has no knowledge on the benefits to the subjects;

• Phase II expands the study to a larger group of people, they may be randomised and placebo controlled. They include participants with a specific illness and go on to determine the proper dosages.

• Phase III expands the study to an even larger group of people, they are comparative and controlled studies. They assess the efficiency and safety of a drug and compare the benefits and side effects with other treatments.

• Phase IV takes place after the drug or treatment has been licensed and marketed. The main reasons for conducting this phase are to find out more about side effects of the drug in a larger population and how well it works in a broader population or in combination with other treatments. Long term risks and benefits are tested by conducting long term follow-up.

Ethical: When a trial is in accordance with the rules/standards for right conduct or practice.

Ethical approval: Research projects have to be reviewed for ethical approval in a number of areas: Is the trial worthwhile? Is it will organised? Is it safe for people taking part? Is it justified by the potential benefit? The approval decision is made by a committee of experts and non-experts who are not connected to the project. This makes sure the trial is safe for participants.

Good Clinical Practice (GCP):International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that subject's rights and confidentiality are protected.

Informed consent: This is when participants learn the key facts about a clinical trial before they decide whether or not to take part. Doctors and nurses involved in the trial will explain the details of the study to help participants decide whether to not to participate. If they choose to participate, they are giving their informed consent.

Licensed drug: In the UK and Europe dru need to be approved by the MHRA/ EMEA before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Dru Application by the manufacturer of the dru, MHRA/ EMEA review of the application, and MHRA/ EMEA approval/rejection of application.

Off-label drug: A drug prescribed for conditions other than those approved by the FDA

Open-label trial: A clinical trial in which doctors and participants know which drug or vacine is being administered.

Orphan drug: In Europe, orphan dru status is granted when the occurrence of the disease doesn’t exceed 5 patients per 10,000 inhabitants.

Placebo: A treatment that does not do anything and will not cause harm. In some trials it is used to compare a new drug to. The placebo will look exactly the same as the other dru, so participants will not be able to tell which one they are receiving. No sick participants receive a placebo if there is known beneficial treatment.

Screening trials: Refers to trials which test the best way to detect certain diseases or health conditions.

Translational research: Studies that provide the bridge between basic research and patient care.

Withdrawal: You or your legal representative is free to withdraw you from the study at any time without penalty or prejudice. The investigator is also free to terminate a patient’s involvement in the study at any time due to medical reasons (e.g. intolerable adverse events).